Institutional Review Board

About the IRB  |  Overview

A. What is the IRB?

The Institutional Review Board (IRB) is a committee operating under Federal regulations, that reviews research involving human subjects to ensure the ethical, safe, and equitable treatment of the subjects.

B. Responsibilities in Studies Involving Human Subjects

1. Institutional Review Board

The IRB is responsible for the health, safety, and well-being of human volunteers in all investigations and NASA-sponsored space flight investigations. The IRB:

Serves as the research ethical committee for ground-based human-subject research, NASA space flight research, research on NASA-sponsored aircraft, selected research at other NASA centers, and NASA-funded research at outside institutions;

Serves as the review committee for all studies involving astronauts (research subjects, research technicians, or human-in-the-loop engineering evaluations) at any NASA Center or external facility;

Serves as the review committee for all studies involving employees (research and engineering evaluations);

Approves, require changes in, or disapproves research involving human subjects;

Establishes and follows written procedures for suspending or terminating previously approved research if warranted by findings in the continuing review or monitoring process;

Has final authority to disapprove human-subject research at NASA (No institutional official may overrule IRB disapproval, but NASA may choose not to support or permit research that the IRB has approved.);

Identifies and analyzes potential sources of risk and measures to minimize risk, including physical, psychological, social, legal, or economic sources;

Determines that the risk to participants are reasonable in relation to potential benefits to participants and to society.

Reviews plans for data and safety monitoring in research protocols and, when applicable, determines that the plan provides adequate protection for the participants.

Evaluates the protection of privacy interests of research participants and confidentiality of data in proposed research.

Reviews the consent process and the consent documents and require that the investigator has and follows a procedure for properly documenting informed consent.

Maintains documentation of its activities.

Operates in compliance under signed current assurances on file with the Office for Human Research Protections (OHRP).

2. Principal Investigators and Staff

Principal Investigators and their research staff must:

Protect the rights and welfare of human research subjects enrolled in research;

Ensure that pertinent laws, regulations, and procedures and guidelines are observed by the participating research team;

Employ sound study design in accordance with the standards of the discipline;

In research involving greater than minimal risk to subjects, implement reporting mechanisms that provide the IRB with plans for promptly detecting harm and mitigating potential injuries;

Maintain appropriate oversight of the research protocols and research staff and delegate appropriately;

Obtain informed consent and ensure that no subject is involved in the research prior to obtaining their consent, using a method of documentation appropriate to the type of research and the study population, and emphasizing the importance of participant comprehension and voluntary participation;

Be qualified by training and experience for their research roles, including knowledge of applicable federal, state and NASA regulations;

Before initiating, modifying, or extending any research project involving human subjects, submit a protocol to the IRB for review and approval;

Disclose any and all potential conflicts of interest that might affect the relationship with the research participants and identify and manage these conflicts;

Disclose whether the submitted protocol has ever been approved or disapproved by another IRB;

Comply with all IRB decisions, conditions, and requirements.

3. NASA Administration

The Chief Health and Medical Officer (CHMO), NASA HQ, ensures that all NASA Centers are in compliance with federal regulations regarding the protection of human subjects in research.

"Review by institution" of paragraph 45 CFR part 46, 46.112 which states: "Research covered by this policy that has been approved by an IRB may be subject to further review and approval or disapproval by officials of the institution. However, those officials may not approve the research if it has not been approved by an IRB."

NASA grants the IRB the authority to function independently of other organizational entities in its role in protecting research participants.

NASA provides legal protection for IRB members and to principal investigators granted approval to conduct such research who have met their obligations in good faith.

NASA is responsible for investigations of individual incidents or allegations of research misconduct.

C. Charge

1. Ethical Principles

NASA is guided in its human research by the "The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research" of April 18, 1979.

Belmont Report

The IRB must review all human subject research protocols with the primary objective of protecting participants from undue risk and from deprivation of personal rights. These protections include the following:

Voluntary participation, without coercion in any form and indicated by free and informed consent;

Freedom for a subject to withdraw from an experiment at any time, for any reason, without penalty;

An appropriate balance between potential benefits of the research to the subject or to society and the risks assumed by the subject;

Fair procedures and outcomes in the selection of the research subjects.

Three principles form the basis of ethical research:

Respect for Persons: Any person who is to be a subject of research, whether designed for his/her direct benefit or for the advancement of scientific knowledge in general, must understand as completely as possible what is to be done and what the potential risks and benefits are. The person must give his/her consent freely, without pressure or inappropriate inducement.

Beneficence: Before any human subject participates in a research study at NASA, the IRB must consider whether:

"The risks to the subject are so outweighed by the sum of the benefit to the subject and the importance of the knowledge to be gained as to warrant a decision to allow the subject to accept those risks" (Federal Register, May 30, 1974).

While the IRB is not charged with reviewing scientific design and merit, it must sometimes do so in order to assess risk/benefit ratio. If a study design does not seem adequate to attain the stated aim of the investigation, then no benefit can be anticipated from conducting the study, and there is no justification for placing the subject at risk, however minimal. The design of the study must be sound, and the nature and likelihood of all risks and benefits must be made clear in any application.

Justice: Both the risks and potential benefits of research should be spread fairly among potential individual subjects and subject groups.

D. IRB Meeting Location

Meetings are conducted on Teams from 10:00 a.m. to 12:30 p.m. CT on the following dates.

E. IRB Calendar of Meeting Dates

Thursday, Oct 21, 2021

(Submit by: Oct 4, 2021)

Thursday, Nov 18, 2021

(Submit by: Nov 1, 2021)

Thursday, Dec 9, 2021

(Submit by: Nov 22, 2021)

F. HRMRB Calendar of Meeting Dates

Wednesday, Oct 27, 2021

(Submit by: Sept 27, 2021)

G. NASA Multiple Project Assurance (MPA)

NASA Multiple Project Assurance (MPA) - NASA Compliance with U.S. Department of Health & Human Services (DHHS) Regulations for Protection of Human Research Subjects

NASA Multiple Project Assurance (MPA) acceptance code: NASA 7116301606HR- Expires June 30, 2021

H. Federal Wide Assurance (FWA)

Federal Wide Assurance (FWA) - NASA Compliance with U.S. Department of Health & Human Services (DHHS) Office for Human Research Protections (OHRP)

NASA Federal Wide Assurance (FWA) acceptance code: FWA00019876 - Expires February 9, 2022